Incidence, predictors, and prognostic significance of impaired functional status early after transcatheter aortic valve replacement.

INTRODUCTION AND OBJECTIVES: There are scarce data on the factors associated with impaired functional status after transcatheter aortic valve replacement (TAVR) and its clinical impact. This study aimed to determine the incidence, predictors, and prognostic implications of impaired functional class (NYHA class III-IV) following TAVR. METHODS: This multicenter study included 3462 transarterial TAVR patients receiving newer generation devices. The patients were compared according to their NYHA class at 1 month of follow-up (NYHA I-II vs NYHA III-IV). A multivariate logistic regression was performed to identify the predictors of 30-day NYHA class III-IV. Patient survival was compared with the Kaplan-Meier method and factors associated with decreased survival were identified with Cox regression analysis. RESULTS: The mean age of the study population was 80.3±7.3 years, with 47% of women, and a median Society of Thoracic Surgeons score of 3.8% [IQR, 2.5-5.8]. A total of 208 patients (6%) were in NYHA class III-IV 1 month after TAVR. Predictors of 30-day NYHA class III-IV were baseline NYHA class III-IV (OR, 1.76; 95%CI, 1.08-2.89; P=.02), chronic pulmonary obstructive disease (OR, 1.80; 95%CI, 1.13-2.83; P=.01), and post-TAVR severe mitral regurgitation (OR, 2.00; 95%CI, 1.21-3.31; P<.01). Patients in NYHA class III-IV 1 month after TAVR were at higher risk of death (HR, 3.68; 95%CI, 2.39-5.70; P<.01) and heart failure-related hospitalization (HR, 6.00; 95%CI, 3.76-9.60; P<.01) at 1-year follow-up. CONCLUSIONS: Up to 6% of contemporary TAVR patients exhibited an impaired functional status following TAVR. Worse baseline NYHA class, chronic pulmonary obstructive disease, and severe mitral regurgitation predicted 30-day NYHA class III/IV, and this determined a higher risk of mortality and heart failure hospitalization at 1-year follow-up. Further studies on the prevention and treatment optimization of patients with impaired functional status after TAVR are needed.

Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial.

BACKGROUND: The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. OBJECTIVES: This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. METHODS: This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire. RESULTS: A total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported. CONCLUSIONS: The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383).

Transcatheter aortic valve implantation in patients with extra-small aortic annuli.

BACKGROUND: A small aortic annulus (SAA) is a risk factor for prosthesis-patient mismatch (PPM) in patients undergoing surgical or transcatheter aortic valve implantation (TAVI). Data regarding TAVI in patients with extra-SAA are scarce. AIMS: The aim of this study was to analyse the safety and efficacy of TAVI in patients with extra-SAA. METHODS: A multicentre registry study including patients with extra-SAA (defined as an aortic annulus area <280 mm2 and/or perimeter <60 mm) undergoing TAVI was established. Primary efficacy and safety endpoints were defined as device success and early safety at 30 days, respectively, using the Valve Academic Research Consortium-3 criteria, and were analysed according to valve type: self-expanding (SEV) versus balloon-expandable (BEV). RESULTS: A total of 150 patients were included, of which 139 (92.7%) were women, and 110 (73.3%) received an SEV. Intraprocedural technical success was 91.3%, with a higher rate in patients receiving an SEV (96.4% vs 77.5% with BEV; p=0.001). Overall, 30-day device success was 81.3%, (85.5% with SEV vs 70.0% with BEV; p=0.032). The primary safety endpoint occurred in 72.0% of patients (with no difference between groups; p=0.118). Severe PPM occurred in 12% (9.0% with SEV and 24.0% with BEV; p=0.039), with no impact on all-cause mortality, cardiovascular mortality, or heart failure readmission at 2-year follow-up. CONCLUSIONS: TAVI is a safe and feasible treatment in patients with extra-SAA with a high rate of technical success. The use of SEV was associated with a lower rate of intraprocedural complications, higher device success at 30 days and better haemodynamic outcomes compared to BEV.

Global Longitudinal Strain Predicts Outcomes in Patients with Reduced Left Ventricular Function Undergoing Transcatheter Edge-to-Edge Mitral Repair.

BACKGROUND: The timing and selection of optimal candidates for mitral transcatheter edge-to-edge valve repair remains to be fully determined, especially in cases with severely depressed left ventricular ejection fraction (LVEF). The objective of this study is to evaluate the prognostic value of myocardial strain (LVGLS) in this setting. METHODS: Retrospectively, 172 consecutive patients with LVEF ≤40% and severe MR treated with MitraClip were included. Four groups were generated according to the LVEF (<30% or ≥30%) and median LVGLS. The primary end-point was cardiovascular mortality. RESULTS: Procedural success was high (96.5%) and complications were rare. At one-year follow-up, 82.5% of patients maintained MR grade ≤2, 79.2% were at a NYHA class ≤II and a reduction of 80% in heart failure admissions was observed in all groups. Interestingly, among patients with a more depressed LVEF, LVGLS was found to be an independent predictor for cardiovascular mortality (HR: 3.3; 95% CI: 1.1-10, p = 0.023). CONCLUSIONS: Mitral valve repair with MitraClip is safe and it improves the mid-term functional class of patients regardless of LVEF. LVGLS can help in the selection of optimal candidates and timing for this procedure, as well as in the recognition of those patients with worse prognoses.

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Complex Coronary Artery Disease.

OBJECTIVES: The aim of this study was to compare, in a cohort of patients with complex coronary artery disease (CAD) and severe aortic stenosis (AS), the clinical outcomes associated with transfemoral transcatheter aortic valve replacement (TAVR) (plus percutaneous coronary intervention [PCI]) versus surgical aortic valve replacement (SAVR) (plus coronary artery bypass grafting [CABG]). BACKGROUND: Patients with complex CAD were excluded from the main randomized trials comparing TAVR with SAVR, and no data exist comparing TAVR + PCI vs SAVR + CABG in such patients. METHODS: A multicenter study was conducted including consecutive patients with severe AS and complex CAD (SYNTAX [Synergy Between PCI with Taxus and Cardiac Surgery] score >22 or unprotected left main disease). A 1:1 propensity-matched analysis was performed to account for unbalanced covariates. The rates of major adverse cardiac and cerebrovascular events (MACCE), including all-cause mortality, nonprocedural myocardial infarction, need for new coronary revascularization, and stroke, were evaluated. RESULTS: A total of 800 patients (598 undergoing SAVR + CABG and 202 undergoing transfemoral TAVR + PCI) were included, and after propensity matching, a total of 156 pairs of patients were generated. After a median follow-up period of 3 years (interquartile range: 1-6 years), there were no significant differences between groups for MACCE (HR for transfemoral TAVR vs SAVR: 1.33; 95% CI: 0.89-1.98), all-cause mortality (HR: 1.25; 95% CI: 0.81-1.94), myocardial infarction (HR: 1.16; 95% CI: 0.41-3.27), and stroke (HR: 0.42; 95% CI: 0.13-1.32), but there was a higher rate of new coronary revascularization in the TAVR + PCI group (HR: 5.38; 95% CI: 1.73-16.7). CONCLUSIONS: In patients with severe AS and complex CAD, TAVR + PCI and SAVR + CABG were associated with similar rates of MACCE after a median follow-up period of 3 years, but TAVR + PCI recipients exhibited a higher risk for repeat coronary revascularization. Future trials are warranted.

Left Atrial Appendage Occlusion as Adjunctive Therapy to Anticoagulation for Stroke Recurrence.

BACKGROUND: Stroke recurrence despite optimal oral anticoagulation (OAC) might represent a novel indication for left atrial appendage occlusion (LAAO). The heterogeneity of these patients is generally high, as the presence of valvular atrial fibrillation (VAF) is common. The aim of this study was to explore the role of LAAO as an adjunctive therapy to OAC in patients with recurrent stroke despite optimal OAC. METHODS: The study screened consecutive patients who underwent percutaneous LAAO at nine centers between 2009 and 2017. Patients with recurrent stroke despite optimal OAC were selected and those with an absolute or relative contraindication to OAC were not included in the study. RESULTS: Among 837 patients who underwent LAAO between the study period, a total of 22 (2.6%) met the inclusion criteria. There was a high percentage of VAF (38%) and 59% presented more than one cardioembolic event before LAAO. All patients underwent successful implantation of the device and no procedural major adverse events were reported. In all but 3 patients, anticoagulation was continued after LAAO. With a median clinical follow-up of 1.8 years (range, 0.7-2.8 years), only 1 stroke and 1 transient ischemic attack were reported, translating into a significant reduction of cerebrovascular events before and after LAAO (2.0 ± 1.0 events vs 0.1 ± 0.3 events; P<.01). Imaging follow-up revealed only 1 case of device thrombosis. CONCLUSIONS: LAAO as an adjunctive therapy to OAC seems to be feasible and safe in patients with previous cardioembolic events despite optimal OAC. In our series, this strategy was associated with a low rate of cerebrovascular events after LAAO.

Incidence, Predictors, and Prognostic Value of Acute Kidney Injury Among Patients Undergoing Left Atrial Appendage Closure.

OBJECTIVES: The aims of this registry were to determine the incidence, predictors, and prognostic value of periprocedural acute kidney injury (AKI) after left atrial appendage closure (LAAC). BACKGROUND: No data exist on the occurrence of AKI after LAAC. METHODS: A total of 355 patients undergoing LAAC were included in the study. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, after the procedure or the need for hemodialysis during index hospitalization. RESULTS: The incidence of AKI was 9%, and patients with worse baseline renal function were at higher risk for developing AKI (odds ratio: 1.32; 95% confidence interval [CI]: 1.09 to 1.61; p = 0.004 for each 10 ml/min decrease in glomerular filtration rate). In-hospital bleeding events occurred more frequently in the AKI group (5.3% vs. 15.6%; p = 0.037). After a median follow-up period of 18 months, patients in the AKI group had higher mortality (hazard ratio [HR]: 2.59; 95% CI: 1.36 to 4.92; p = 0.004), more embolic events (HR: 6.14; 95% CI: 2.23 to 16.92; p = 0.001) and major bleeding events (HR: 2.36; 95% CI: 0.89 to 6.24; p = 0.083). The occurrence of AKI was an independent predictor of midterm mortality (HR: 2.00; 95% CI: 1.02 to 3.91; p = 0.044). CONCLUSIONS: The occurrence of AKI was relatively frequent following LAAC, and patients with lower renal glomerular filtration rates were at high risk for developing this complication. AKI identified a group of patients with worse midterm outcomes, highlighting the importance of further preventive strategies in this population.

Long-term outcomes following percutaneous left atrial appendage closure in patients with atrial fibrillation and contraindications to anticoagulation.

PURPOSE: We aimed to evaluate the late clinical outcomes of percutaneous LAA closure in patients with atrial fibrillation (AF) and contraindication to oral anticoagulation. METHODS: Consecutive AF patients with contraindications to oral anticoagulation who underwent successful LAA closure between December 2008 and March 2013 at four centers were included. RESULTS: A total of 101 patients (median age 76 [IQR 69-80] years, 48% women, mean CHA2DS2-VASc 5 ± 2; HAS-BLED 4 ± 1) were included. Eighty-six (85.1%) patients received an Amplatzer Cardiac Plug/Amulet device and 15 (14.9%) patients a Watchman device. The mean follow-up period was 4 ± 1 years. During 358.6 patient-years of follow-up, 7 (6.9%) patients suffered a major stroke (2 cases per 100 person-years; expected rate: 6.2 cases per 100 person-years), and 20 (19.8%) patients experienced at least one episode of major bleeding (6.4 cases per 100 person-years; expected rate: 9.0 cases per 100 person-years). There were no cases of late adverse events related to the device. A total of 34 (33.7%) patients died during follow-up (9.5 cases per 100 person-years). Older age, male sex, low ejection fraction, and chronic kidney disease were identified as predictive factors of late mortality. CONCLUSIONS: Percutaneous LAA closure is safe and effective in the long term in patients with AF with contraindications to anticoagulation. However, a high long-term mortality rate was observed in this high-risk population. Comprehensive patient assessment prior to undergoing LAA closure should identify patients in whose comorbidities limit their overall prognosis.

Transcatheter valve-in-valve overexpansion for treating a large dysfunctional tricuspid bioprosthesis.

Transcatheter valve-in-valve implantation within dysfunctional surgical bioprosthesis has become an alternative to redo open-heart surgery. However, suitability for valve-in-valve implantation in the tricuspid position is often limited by large surgical valve sizes. We report a case of a transcatheter tricuspid valve-in-valve implantation with a 29-mm balloon-expandable prosthesis within a 33-mm failed bioprosthesis (exceeding manufacturer's sizing recommendations). Overexpansion of a 29-mm SAPIEN XT valve by 1-ml overfilling of the deployment balloon was successfully performed, with no valve dislocation/embolization or residual tricuspid regurgitation. This case illustrates the feasibility of tricuspid valve-in-valve procedures in selected patients with large failed tricuspid bioprostheses.

Transcatheter treatment of functional tricuspid regurgitation: preliminary experiences.

Tricuspid regurgitation (TR) is a common finding in patients with left-sided valvular or myocardial disease. However, many patients with severe symptomatic TR are deemed inoperable or at high surgical risk, often due to comorbidities and the need for redo sternotomy. Thus, despite the poor prognosis associated with this condition, few patients undergo isolated surgical tricuspid valve repair. Therefore, there is an unmet clinical need for less invasive therapeutic options for these patients. In recent times, several transcatheter therapies have emerged for treating TR, with promising safety and preliminary efficacy results. In this review, we describe the main features of and clinical results associated with such devices, and describe the ongoing and future studies in the field.

Right atrial thrombosis associated with hemodialysis catheter: first description of recurrence in a poorly understood problem.

Catheter-related right atrial thrombosis (CRAT) is an underreported and potentially life-threatening complication of central venous catheter in hemodialysis patients. The accurate incidence is unknown, with reported rates ranging from 2 to 12.8% [1] in series, up to 29% [2] in a postmortem prospective study, and high mortality rates (18%) [1]. The optimal treatment for CRAT is controversial and nonsystematized, including anticoagulation, thrombolysis, and surgical thrombectomy. We report two cases of CRAT in dialysis patients, who underwent surgical thrombectomy. One case required reintervention because of recurrence, a first reported case in hemodialysis population.